A New Path Forward.

Canvas Dx is the first FDA-authorized1 Software as a Medical Device (SaMD)2 that aids physicians in diagnosing autism spectrum disorder (ASD) in young children3

Canvas Dx harnesses clinically validated3 artificial intelligence (AI) technology to aid physicians in diagnosing ASD in children between the ages of 18 and 72 months who are at risk of developmental delay

Canvas Dx has the potential to facilitate early diagnosis in children with ASD3

How does Canvas Dx work?

Canvas Dx incorporates 3 separate, user-friendly inputs:3

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A parent/caregiver questionnaire that asks about the child’s behavior and development collected via a parent/caregiver facing app

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2 videos of the child interacting in their natural environment, recorded by the caregiver, then analyzed by a specially-trained video analyst*

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An HCP questionnaire completed by a physician** who meets with the child and a parent/caregiver, collected via a healthcare provider portal

*Trained professional with at least a Master's degree and at least 5 years diagnosing and/or treating children with ASD.
**One of Canvas Dx’s device inputs is a 13 or 15 item age-dependent healthcare provider (HCP) questionnaire collected via a healthcare provider portal. 

The Canvas Dx algorithm then evaluates all 3 inputs, generating a device output that the Primary Care Physician (PCP) utilizes in combination with their clinical judgement3

For Caregivers

User Guide

For Healthcare Providers

User Guide

Because most ASD-specific interventions require a formal ASD diagnosis, delays can result in missed opportunities during a critical window in the child’s neurodevelopment11,21

Why Canvas Dx?

Canvas Dx can aid PCPs in diagnosing ASD in children starting at 18 months of age3 during a critical period when interventions are shown to provide/lead to improved long-term outcomes.4-8

While a child as young as 18 months can be reliably diagnosed with ASD,9 multiple factors have driven the average age of diagnosis to 4 years and 2 months,10 an average delay of 3 years between parental concern and a formal ASD diagnosis.11


Long Wait Times

A shortage of specialists 12,13 and time-intensive evaluations14,15 result in long wait times for diagnostic appointments, causing substantial delays in diagnosis.16


Lack of Access

Children who are non-white, female, from rural areas or from disadvantaged socioeconomic backgrounds are often diagnosed later than the average delay reported or missed altogether.17-19


Delayed Referrals

Because there is no standard diagnostic process for ASD and there are multiple types of specialists for referral, there is no clear pathway for PCPs.20

How AI Works

AI uses pattern recognition to uncover clinically meaningful relationships that exist between signs, symptoms, and behaviors. In addition, AI approaches are suitable for aiding medical diagnosis. They can unlock clinically relevant information hidden in healthcare data and identify complex non-linear patterns between patient features and diagnosis.22-25

How Canvas Dx Works

Canvas Dx harnesses the power of artificial intelligence (AI) to aid primary care physicians (PCPs) in the identification of autism spectrum disorder (ASD).3

Canvas Dx's AI / machine learning algorithm can be optimized to improve accuracy by training on new data.

The Canvas Dx algorithm (v2) was optimized by training on new data
and has the following performance metrics:

  • Negative Predictive Value (NPV) of 95.6%
  • Positive Predictive Value (PPV) of 87.5%
  • Determinate rate (rate for Canvas Dx to provide either a positive or negative for ASD result) of 66.5%

Good machine learning practices26 were followed in the algorithm update, as the industry standard in the field of AI/ML.


Pivotal Study Results

The Canvas Dx pivotal study measured the performance of the Device with algorithm v1 in aiding the diagnosis of autism spectrum disorder (ASD), compared to specialist evaluation using DSM-5 criteria.3

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The accuracy of Canvas Dx was assessed in comparison to the standard diagnostic approach (specialist evaluation and diagnosis) in a multisite, prospective, double-blinded, active comparator cohort study. The study included 425 children, aged 18-72 months, with parental or PCP concern for developmental delay.3

Access the Pivotal Study
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How Canvas Dx Helps


When used in conjunction with a physician's clinical assessment, Canvas Dx can accurately aid diagnosis starting at 18 months of age3 during a critical window in a child’s neurodevelopment.4


By helping PCPs diagnose or rule out ASD, remotely or in person, Canvas Dx has the potential to expand the group of diagnosing physicians and may allow for more efficient specialty referrals.3

Use of Canvas Dx may allow children with ASD to be diagnosed over 1.5 years earlier than the current average age of diagnosis3,10

The average age of children with a positive output in the Canvas Dx pivotal trial was 2.8 years3, whereas the current average age of diagnosis is 4 years, 2 months10